An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
3 other identifiers
interventional
279
7 countries
61
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Jul 2011
Shorter than P25 for phase_2 diabetes-mellitus-type-2
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2011
CompletedFirst Posted
Study publicly available on registry
April 22, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
September 1, 2014
CompletedSeptember 16, 2014
September 1, 2014
9 months
April 21, 2011
August 20, 2014
September 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c From Baseline to Week 18
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 18
Secondary Outcomes (3)
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18
Day 1 (Baseline) and Week 18
Percent Change in Body Weight From Baseline to Week 18
Day 1 (Baseline) and Week 18
Percentage of Patients With HbA1c <7% at Week 18
Week 18
Study Arms (3)
Canagliflozin 50 mg bid
EXPERIMENTALEach patient will receive 50 mg canagliflozin twice daily for 18 weeks.
Canagliflozin 150 mg bid
EXPERIMENTALEach patient will receive 150 mg canagliflozin twice daily for 18 weeks
Placebo
PLACEBO COMPARATOREach patient will receive matching placebo twice daily for 18 weeks
Interventions
One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks
1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks
The patient's stable daily dose of Metformin background therapy should be continued throughout the study.
Eligibility Criteria
You may qualify if:
- All patients must have a diagnosis of T2DM and be currently treated with metformin
- Patients in the study must have a HbA1c between \>=7 and \<=10.5%
- Patients must have a fasting plasma glucose (FPG) \<270 mg/dL (15 mmol/L)
You may not qualify if:
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Unknown Facility
Little Rock, Arkansas, United States
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National City, California, United States
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Spring Valley, California, United States
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Bradenton, Florida, United States
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Marianna, Florida, United States
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Savannah, Georgia, United States
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Avon, Indiana, United States
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Valparaiso, Indiana, United States
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Madisonville, Kentucky, United States
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Metairie, Louisiana, United States
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Charlotte, North Carolina, United States
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Columbus, Ohio, United States
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Mason, Ohio, United States
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Perrysburg, Ohio, United States
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Tulsa, Oklahoma, United States
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Yukon, Oklahoma, United States
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Oregon City, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Pearland, Texas, United States
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San Antonio, Texas, United States
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Bountiful, Utah, United States
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Virginia Beach, Virginia, United States
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Milwaukee, Wisconsin, United States
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Toronto, Ontario, Canada
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Saskatoon, Saskatchewan, Canada
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Beroun, Czechia
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Olomouc, Czechia
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Ostrava, Czechia
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Pardubice, Czechia
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Písek, Czechia
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Prague, Czechia
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Znojmo, Czechia
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Aguascalientes, Mexico
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Guadalajara, Jalisco., Mexico
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Monterrey, Mexico
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Tampico, Mexico
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Bacau, Romania
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Galati, Romania
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Târgu Mureş, Romania
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Kursk, Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Tyumen, Russia
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Voronezh, Russia
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Banská Bystrica, Slovakia
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Bratislava, Slovakia
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Košice, Slovakia
Unknown Facility
Prešov, Slovakia
Unknown Facility
Šahy, Slovakia
Unknown Facility
Trebišov, Slovakia
Related Publications (1)
Qiu R, Capuano G, Meininger G. Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus. J Clin Transl Endocrinol. 2014 May 5;1(2):54-60. doi: 10.1016/j.jcte.2014.04.001. eCollection 2014 Jun.
PMID: 29159083DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2011
First Posted
April 22, 2011
Study Start
July 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
September 16, 2014
Results First Posted
September 1, 2014
Record last verified: 2014-09